Pharma manufacturer minimizes compliance risk in batch delivery

Background

With a significant focus on pharmaceutical manufacturing, this $15B organization operates multiple manufacturing locations in the USA, Central and South Americas, Europe and Japan, and specializes in developing and delivering a wide range of health and wellness products. Their operations involve meticulous batch delivery workflows, quality assurance processes, and strict adherence to global regulatory standards, as expected in the consumer health industry.

Challenges

The manufacturer struggled with managing the many different types of files required in their batch delivery workflows. They needed to convert all these files into PDFs for uniform storage, but the diverse range of materials - like product specifications, ingredients, formulas, raw materials, and packaging details - added complexity. This made it hard to keep a consistent and efficient document management system, leading to several issues:

1. Process Inefficiencies: The manual effort required to handle various file types and ensure their proper rendering into PDFs was time-consuming and resource-intensive.
2. Documentation Inconsistencies: Variability in file formats and the manual conversion process led to inconsistencies in documentation, affecting the accessibility and reliability of critical information.
3. Compliance Risks: Inconsistent documentation and inefficient workflows posed significant compliance risks, threatening the company’s adherence to stringent industry regulations.

Solution

The organization implemented Adlib into their Dassault's Enovia batch delivery, quality assurance, and manufacturing workflows, capturing batch records from a variety of sources, such as eQMS, MES, email inbox and DMS. Adlib's robust rendering capabilities allows for the automatic conversion of all file types into standardized PDFs, smart assembly, OCR and technical validation, regardless of their origin.

This implementation brought several key benefits:

1. Streamlined Document Management: Adlib ensures that all materials, from product specifications to packaging specifics, are consistently and efficiently stored as PDFs. This eliminates the need for manual conversions and reduces 90% of errors.
2. Increased Efficiency: By automating the rendering process, the company achieved greater efficiency in their workflows. The reduction in manual effort allowes employees to focus on more critical tasks, improving productivity by 20%.
3. Enhanced Consistency and Accessibility: The standardization of document formats improved the consistency and accessibility of information, saving up to 80% of time and resources for teams to locate and retrieve necessary documents.
4. Improved Compliance and Operational Efficiency: The automation and standardization provided by Adlib enhanced the company's compliance with regulatory standards, eliminating 100% of negative audit outcomes and FDA citations associated with 21 CFR Part 211.

“Every file type is rendered through Adlib as all materials are required to be stored as PDFs. The files we are processing can be a mixture of different things such as product specifications, ingredients, formulas, raw materials used in products, or specifics of packaging. Adlib is integrated with Enovia, our active quality management tool. We rely heavily on that tool,”– Sr. Manager Platform